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FDA discusses the agencys surrogate endpoint (SE) table that was mandated by the 21st Century Cures Act of 2016.[ Price : $8.95]
Federal Register notice. FDA makes available three device-specific final guidance documents for the Safety and Performance Based P...[ Price : $8.95]
FDA approves Revivicors intentional genomic alteration in GalSafe pigs for use as food and human therapeutics.[ Price : $8.95]
Federal Register notice: FDA corrects an 11/25 notice entitled Qualification Process for Drug Development Tools; Guidance for Indu...[ Price : $8.95]
Federal Register notice: FDA is withdrawing approval of 10 ANDAs from multiple applicants after they notified the agency that the ...[ Price : $8.95]
Federal Register notice: FDA extends the comment period on a draft guidance entitled Electromagnetic Compatibility of Medical Devi...[ Price : $8.95]
Federal Register notice: FDA announces the renewal of its Bone, Reproductive and Urologic Drugs Advisory Committee for an addition...[ Price : $8.95]
FDA grants Lexicon Pharmaceuticals a fast track designation for LX9211 and its use in treating diabetic peripheral neuropathic pai...